乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数500
标示量(mg)30供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.063382353390613378963378973382123382600.15
214.973407263392533399900.31
单位质量响应值RSD%判断
22460.8222711.420.79数据可信
供试品溶液-24101001-1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min147413-4741312.27312.423.0512.2712.423.05
249488-4948812.81012.81
347495-4749512.29412.29
449871-4987112.90912.91
545923-4592311.88711.89
647748-4774812.36012.36
60min185935-8593522.24522.292.8022.2722.312.80
289277-8927723.11023.13
386954-8695422.50922.53
486498-8649822.39122.41
581876-8187621.19421.21
686118-8611822.29222.31
120min1141762-14176236.69636.803.1736.7536.863.17
2148135-14813538.34638.41
3146179-14617937.83937.90
4141353-14135336.59036.65
5135581-13558135.09635.15
6139882-13988236.20936.27
240min1218708-21870856.61456.722.6156.7356.842.61
2227390-22739058.86258.99
3224533-22453358.12258.24
4215429-21542955.76555.89
5212687-21268755.05655.17
6215880-21588055.88256.00
360min1270584-27058470.04369.642.2270.2669.862.22
2277224-27722471.76171.98
3274491-27449171.05471.27
4263079-26307968.10068.31
5264128-26412868.37168.58
6264743-26474368.53168.74
480min1310477-31047780.36980.481.5980.7080.811.59
2317314-31731482.13982.48
3314702-31470281.46381.80
4303129-30312978.46778.79
5311293-31129380.58080.90
6308591-30859179.88180.21
600min1329443-32944385.27985.211.4085.7485.671.40
2335142-33514286.75487.23
3331481-33148185.80686.28
4321190-32119083.14283.60
5329234-32923485.22585.68
6328576-32857685.05485.51
720min1340549-34054988.15488.041.5188.7688.651.51
2346134-34613489.59990.22
3342764-34276488.72789.34
4330991-33099185.67986.28
5341588-34158888.42389.02
6338633-33863387.65888.26
960min1352880-35288091.34691.271.6492.1092.021.64
2360279-36027993.26194.03
3355659-35565992.06592.83
4343004-34300488.78989.53
5353486-35348691.50292.25
6350242-35024290.66391.41
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1359336-35933693.01792.881.5593.9293.781.55
2366359-36635994.83595.76
3361076-36107693.46794.38
4349569-34956990.48891.37
5359814-35981493.14094.04
6356659-35665992.32493.22
1440min1362385-36238593.80693.781.8194.8794.841.81
2372283-37228396.36897.45
3364439-36443994.33895.41
4352285-35228591.19192.23
5362943-36294393.95095.00
6359300-35930093.00794.06
极限1363475-36347594.08894.001.8195.3095.221.81
2372063-37206396.31197.56
3364046-36404694.23695.47
4351987-35198791.11492.30
5365755-36575594.67895.89
6361499-36149993.57794.78
乌帕替尼缓释片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数500
标示量(mg)30供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.063382843380343380913383733382893382140.05
214.973391903391533391720.01
单位质量响应值RSD%判断
22457.7722656.780.63数据可信
供试品溶液-24101001-2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min152232-5223213.53812.165.9513.5412.165.95
245719-4571911.85011.85
345053-4505311.67711.68
444996-4499611.66211.66
547705-4770512.36412.36
645741-4574111.85511.86
60min186323-8632322.37421.861.9122.4021.881.92
282892-8289221.48421.50
384470-8447021.89321.91
482503-8250321.38421.40
586082-8608222.31122.33
683717-8371721.69821.72
120min1141423-14142336.65536.141.0236.7136.201.01
2138984-13898436.02336.08
3137238-13723835.57035.63
4139913-13991336.26336.32
5140171-14017136.33036.39
6138982-13898236.02236.08
240min1215253-21525355.79055.570.7855.9155.680.77
2215634-21563455.88956.00
3213833-21383355.42255.54
4211251-21125154.75354.87
5215007-21500755.72755.84
6215356-21535655.81755.93
360min1264868-26486868.65068.330.9968.8668.540.98
2265968-26596868.93569.14
3260220-26022067.44567.65
4260891-26089167.61967.83
5263602-26360268.32268.53
6266348-26634869.03369.24
480min1306477-30647779.43478.961.2379.7679.281.23
2305964-30596479.30179.63
3299142-29914277.53377.85
4301445-30144578.13078.45
5305320-30532079.13479.46
6309451-30945180.20580.53
600min1324689-32468984.15583.721.4184.6284.171.41
2324809-32480984.18684.64
3317339-31733982.25082.70
4318732-31873282.61183.06
5322585-32258583.60984.07
6329818-32981885.48485.94
720min1335382-33538286.92686.681.3187.5387.271.30
2335807-33580787.03687.63
3328658-32865885.18385.77
4331152-33115285.83086.42
5334162-33416286.61087.21
6341349-34134988.47389.07
960min1350358-35035890.80889.921.5091.5590.661.50
2347227-34722789.99690.74
3340391-34039188.22488.95
4343107-34310788.92889.66
5345583-34558389.57090.31
6354947-35494791.99792.74
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1354509-35450991.88491.691.2092.7892.581.20
2354287-35428791.82692.72
3349857-34985790.67891.55
4349761-34976190.65391.53
5352794-35279491.43992.33
6361306-36130693.64594.55
1440min1358194-35819492.83992.431.2593.8993.481.25
2357576-35757692.67893.72
3350177-35017790.76191.79
4354175-35417591.79792.83
5356155-35615592.31093.35
6363503-36350394.21595.27
极限1358432-35843292.90092.401.3394.1193.601.32
2358155-35815592.82994.03
3349800-34980090.66391.84
4353525-35352591.62892.81
5355547-35554792.15393.35
6363553-36355394.22895.44
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